Corticosteroids With Placebo Versus Corticosteroids With Propranolol Treatment of Infantile Hemangiomas (IH)
Information source: Seattle Children's Hospital
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Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hemangioma
Intervention: Prednisolone (Corticosteroid) (Drug); Propranolol (Drug); Placebo (Drug)
Phase: Phase 2
Sponsored by: Seattle Children's Hospital
Official(s) and/or principal investigator(s):
Jonathan A Perkins, DO, Principal Investigator, Affiliation: Seattle Children's Hospital
This is a prospective randomized, double-blind study to compare the clinical efficacy of
infantile hemangioma treatment using propranolol with corticosteroids as compared to therapy
with corticosteroids and placebo. We hypothesize that a two-month treatment period with
propranolol plus corticosteroids is more effective at reducing infantile hemangioma size and
vascularity when compared to corticosteroids used without propranolol for the same time
Official title: A Phase II, Randomized, Double-Blind Comparison of Corticosteroid and Corticosteroids With Propranolol Treatment of Infantile Hemangiomas (IH)
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Compare Changes in IH Size and Vascularity for Subjects Randomized to Receive Initial Treatment With Corticosteroid-only Therapy Versus Combination Therapy With Corticosteroids Plus Propranolol
Determine Therapeutic Response of IH to Propranolol Among Patients Who Switch to Corticosteroids Plus Propranolol Therapy After Failing to Respond to Corticosteroids Alone.
Assess the Safety of Propranolol With Corticosteroids and Corticosteroids Alone in the Treatment of IH.
Demonstrate How Duplex Scanning to Assess Blood Vessel Density and Qualitative Color Ratings of Cutaneous Lesions From Photographs Can be Used to Measure and Quantify Changes in IH Size and Vascularity in a Clinically Relevant Manner.
Infantile hemangiomas (IH) are the most common head and neck pediatric tumors. Presence of
these tumors can lead to complications of vision and airway compromise, bleeding and
disfigurement. Medical treatment of these lesions has traditionally been focused on stopping
new blood vessel growth with corticosteroids. Recent reports and our own experience have
demonstrated that significant reduction in IH size and vascularity can also occur through
the use of propranolol. Our initial experience with propranolol has demonstrated
significant efficacy with fewer side effects than corticosteroids. Despite this experience,
the standard of care for initial IH medical therapy remains corticosteroids.
This Trial is a direct comparison of traditional IH therapy with corticosteroids to newer
therapy with propranolol and corticosteroids.
Minimum age: N/A.
Maximum age: 9 Months.
- Age 0 to < 9months
- Patients with clinical, radiographic or histologic diagnosis of infantile hemangioma
(IH) requiring medical treatment
- IH patients whose parents desire medical treatment for the IH
- Stable cardiac function
- IH patients over 9 months of age.
- Hypersensitivity to propranolol
- Untreated heart failure: If the patient has heart failure associated with the
hemangioma, propranolol would be initiated after anti-congestive therapy and under
observation as an in-patient.
- Atrioventricular (AV) block
- Resting heart < 2 SD of normal*(below)
- Resting blood pressure < 2 SD of normal**(below)
- Wolff-Parkinson-White syndrome (WPW)
- History of unexplained syncope
- Bronchial asthma
- History of impaired renal or liver function
- Diabetes mellitus
Locations and Contacts
Seattle Children's Hospital, Seattle, Washington 98105, United States
Seattle Children's Vascular Anomalies Program
Cushing SL, Boucek RJ, Manning SC, Sidbury R, Perkins JA. Initial experience with a multidisciplinary strategy for initiation of propranolol therapy for infantile hemangiomas. Otolaryngol Head Neck Surg. 2011 Jan;144(1):78-84. doi: 10.1177/0194599810390445.
Truong MT, Perkins JA, Messner AH, Chang KW. Propranolol for the treatment of airway hemangiomas: a case series and treatment algorithm. Int J Pediatr Otorhinolaryngol. 2010 Sep;74(9):1043-8. doi: 10.1016/j.ijporl.2010.06.001. Epub 2010 Jul 31.
Starting date: February 2010
Last updated: December 11, 2013